Acetris Health, LLC v. United States ( 2020 )

Case: 18-2399 Document: 53 Page: 1 Filed: 02/10/2020
United States Court of Appeals
for the Federal Circuit
______________________
ACETRIS HEALTH, LLC,
Plaintiff-Appellee
v.
UNITED STATES,
Defendant-Appellant
______________________
2018-2399
______________________
Appeal from the United States Court of Federal Claims
in No. 1:18-cv-00433-MMS, Chief Judge Margaret M.
Sweeney.
______________________
Decided: February 10, 2020
______________________
STEPHEN E. RUSCUS, Morgan, Lewis & Bockius LLP,
Washington, DC, argued for plaintiff-appellee. Also repre-
sented by JAMES D. NELSON, DAVID B. SALMONS, DONNA
LEE YESNER.
DANIEL B. VOLK, Commercial Litigation Branch, Civil
Division, United States Department of Justice, Washing-
ton, DC, argued for defendant-appellant. Also represented
by JOSEPH H. HUNT, ROBERT EDWARD KIRSCHMAN, JR.,
PATRICIA M. MCCARTHY; JENNIFER CLAYPOOL, Procure-
ment Law Group, United States Department of Veterans
Affairs, Hines, IL.
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2 ACETRIS HEALTH, LLC v. UNITED STATES
KYLE R. JEFCOAT, Latham & Watkins LLP, Washing-
ton, DC, for amicus curiae The Association for Accessible
Medicines. Also represented by GENEVIEVE PATRICIA
HOFFMAN; JEFFREY FRANCER, The Association for Accessi-
ble Medicines, Washington, DC.
______________________
Before DYK, PLAGER, and STOLL, Circuit Judges.
DYK, Circuit Judge.
This case concerns restrictions on the procurement of
foreign-origin pharmaceutical products by the Department
of Veterans Affairs (“VA”). The Trade Agreements Act of
1979 (“TAA”) bars the VA from purchasing “products of”
certain foreign countries, such as India. The Federal Ac-
quisition Regulation (“FAR”) directs agencies to purchase
“U.S.-made end products” before end products from certain
foreign countries.
The VA interpreted the statute and regulation to define
the country of origin of a pharmaceutical product to be the
country in which the product’s active ingredient is manu-
factured, here India. Acetris Health, LLC (“Acetris”) chal-
lenged the VA’s interpretation of the TAA and the FAR in
a bid protest action at the United States Court of Federal
Claims (“Claims Court”). The Claims Court granted Ace-
tris declaratory and injunctive relief, holding that the VA
misinterpreted the TAA and the FAR and enjoined the VA,
in future procurements, from utilizing an erroneous inter-
pretation. Acetris Health, LLC v. United States, 138 Fed.
Cl. 579, 606–07 (2018). The government appeals.
We hold that this suit is justiciable and agree with the
Claims Court on the result, but find the Claims Court’s
remedy to be imprecise in certain respects. Accordingly,
we affirm-in-part, vacate-in-part, and remand for the entry
of a declaratory judgment and injunction consistent with
this opinion.
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ACETRIS HEALTH, LLC v. UNITED STATES 3
BACKGROUND
I
Two statutes restrict the government’s ability to pro-
cure foreign-origin products. The first of these statutes to
be enacted, the Buy American Act of 1933 (“BAA”), pro-
vides in relevant part that:
[O]nly manufactured articles, materials, and sup-
plies that have been manufactured in the United
States substantially all from articles, materials, or
supplies mined, produced, or manufactured in the
United States, shall be acquired for public use un-
less the head of the department . . . determines . . .
their cost to be unreasonable.
41 U.S.C. § 8302(a)(1) (emphasis added). A 1954 Executive
Order, now implemented in the FAR, specifies that the un-
reasonable cost exception to the BAA applies where the
lowest domestic offer by a large business is over 6% higher
than the lowest foreign offer, and the lowest domestic offer
by a small business is over 12% higher than the lowest for-
eign offer. 48 C.F.R. (“FAR”) § 25.105. Congress has also
exempted commercial-off-the-shelf (“COTS”) products from
the “substantially all” requirement, 41 U.S.C. § 1907, so a
COTS product “manufactured” in the United States is
BAA-compliant even if it is manufactured from predomi-
nantly foreign components, FAR § 25.101(a)(2). Acetris
contends that this exception applies to its products, and the
government does not contend otherwise.
The second of these statutes is the TAA. The TAA was
designed to encourage foreign countries to enter reciprocal
government-procurement trade agreements. Those agree-
ments prohibit foreign countries from discriminating
against American-made products and prohibit the United
States from discriminating against foreign-origin products.
Under the statute, countries that have entered into such
agreements, and that do not discriminate against
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4 ACETRIS HEALTH, LLC v. UNITED STATES
American-made products, are allowed to compete for U.S.
government procurements on non-discriminatory terms.
At the same time, products from countries that have not
entered into such trade agreements are barred from gov-
ernment procurements. Countries that have entered into
such agreements are described as parties to the World
Trade Organization (“WTO”) Agreement. Section
2512(a)(1) of the TAA provides that:
[T]he President, in order to encourage additional
countries to become parties to the [WTO] Agree-
ment and to provide appropriate reciprocal compet-
itive government procurement opportunities to
United States products and suppliers of such prod-
ucts—
(A) shall, with respect to procurement cov-
ered by the Agreement, prohibit the pro-
curement . . . of products—
(i) which are products of a foreign country
or instrumentality which is not designated
pursuant to section 2511(b) of this title [i.e.,
have not entered into reciprocal trade
agreements], and
(ii) which would otherwise be eligible prod-
ucts [i.e., products covered by the Agree-
ment or another reciprocal trade
agreement] 1. . . .
19 U.S.C. § 2512(a)(1) (emphasis added). The TAA defines
“a product of a country” as follows:
An article is a product of a country or instrumen-
tality only if (i) it is wholly the growth, product, or
manufacture of that country or instrumentality, or
1 See 19 U.S.C. § 2518(4) (defining “eligible prod-
uct”).
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ACETRIS HEALTH, LLC v. UNITED STATES 5
(ii) in the case of an article which consists in whole
or in part of materials from another country or in-
strumentality, it has been substantially trans-
formed into a new and different article of commerce
with a name, character, or use distinct from that of
the article or articles from which it was so trans-
formed.
19 U.S.C. § 2518(4)(B) (emphasis added). Accordingly, for
procurements “covered by the [WTO] Agreement,” the TAA
generally prohibits government procurement of “products
of a foreign country” unless the country is a party to the
“Agreement” referenced in section 2512(a)(1). India, nota-
bly, is not a party to the Agreement. Thus, the TAA bars
procurement of “products of” India. 2
As the government states, “[r]ulings from U.S. Cus-
toms and Border Protection (CBP) had long held that the
source of a pharmaceutical product’s active ingredient gen-
erally dictates its country of origin.” Appellant’s Br. 6. The
VA has adopted the CBP’s interpretation. The central mer-
its question is whether this interpretation is correct, i.e.,
whether the products involved here are “products of a for-
eign country,” i.e., India, under the meaning of the TAA.
Also pertinent here are the provisions of the FAR. The
FAR’s Trade Agreements Clause (“TA Clause”), which har-
monizes and implements the BAA and TAA in contracts
2 The President can “designate[]” (i.e., waive the re-
quirements of the TAA for) a country that is not a party to
the Agreement in certain circumstances, such as if the
country is a “least developed country,” or not a “major in-
dustrial country” and “will provide appropriate reciprocal
competitive government procurement opportunities to
United States products and suppliers of such products.”
See 19 U.S.C. § 2511(b). India has not been “designated”
by the President under section 2511(b).
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6 ACETRIS HEALTH, LLC v. UNITED STATES
covered by the WTO Agreement, states in relevant part
that the “Contractor shall deliver under this contract only
U.S.-made or designated country end products.” FAR
§ 52.225-5.
The FAR defines a “U.S.-made end product” as follows:
U.S.–made end product means an article that is
mined, produced, or manufactured in the United
States or that is substantially transformed in the
United States into a new and different article of
commerce with a name, character, or use distinct
from that of the article or articles from which it was
transformed.
FAR § 25.003.
II
Plaintiff-Appellee Acetris is a generic pharmaceutical
distributor that specializes in providing pharmaceuticals
to the federal government. Acetris obtains many of its
pharmaceutical products from Aurolife Pharma LLC (“Au-
rolife”), which makes them in a facility located in Dayton,
New Jersey using an active pharmaceutical ingredient
(“API”) made in India. In 2017, Acetris had contracts to
supply the VA with at least 13 pharmaceutical products,
including Entecavir Tablets (used to treat hepatitis B).
On March 1, 2017, the VA sent a letter to Acetris re-
questing it to recertify its compliance with the TAA for each
of 13 contracts Acetris then held with the VA. Acetris re-
sponded that its products were “TAA compliant.” J.A. 558.
On March 30, 2017, the VA sent an email to Acetris stating
that Acetris’ response was “insufficient” and “demanded”
that Acetris provide a compliance letter “that followed the
definition of substantial transformation under the TAA, as
set forth in FAR 52.225-5,” which directs agencies to ac-
quire “U.S.-made end products.” J.A. 558. In Acetris’ re-
sponse to this email, it stated that its products were “‘U.S.-
made end products’ as defined in FAR 52.225-5, because
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ACETRIS HEALTH, LLC v. UNITED STATES 7
each is ‘an article that is mined, produced, or manufactured
in the United States or that is substantially transformed in
the United States.’” J.A. 559.
In response, on April 17, 2017, the VA “requested” that
Acetris obtain a country-of-origin determination from the
CBP for each of ten Acetris products. J.A. 558. The VA
reiterated this request in a subsequent letter dated June 6,
2017, stating that it had “probable cause” to believe that
ten of Acetris’ products, including Acetris’ Entecavir Tab-
lets, were made using API made in India, and so were al-
legedly not TAA-compliant. J.A. 559.
Acetris sought such rulings from the CBP and, on Jan-
uary 30, 2018, the CBP issued its country-of-origin deter-
minations, holding that the Acetris products were products
of India because their APIs were made in India and no sub-
stantial transformation had occurred in the United States.
See, e.g., Notice of Issuance of Final Determinations Con-
cerning Certain Pharmaceutical Products, 83 Fed. Reg.
5130–33 (Feb. 5, 2018). Acetris challenged the CBP’s de-
terminations in the Court of International Trade (“CIT”),
contending that its products’ country-of-origin is the
United States. Acetris’ CIT cases are stayed pending reso-
lution of this appeal.
On March 8, 2018, the VA sent a letter to Acetris noting
the CBP’s determination and requesting that Acetris find
another source for each of the Acetris products that CBP
had determined to be products of India. The VA stated that
it was “the VA’s intention to no longer purchase the current
Acetis [sic] products” after March 26, 2018. J.A. 2269. On
April 5, 2018, to avoid termination for default, Acetris
agreed to a no-cost cancellation of its Entecavir contract.
The record does not indicate the disposition of Acetris’
other contracts.
On March 14, 2018, the VA issued a new solicitation
seeking proposals for Entecavir tablets. Acetris again
sought an award of the Entecavir contract. Before the
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8 ACETRIS HEALTH, LLC v. UNITED STATES
submission deadline, Acetris sent the VA five questions
concerning the solicitation. The VA’s response indicated
that it would continue to rely on the CBP’s determination,
stating: “[t]he substantial [transformation] determination
is determined by [CBP]” and “[CBP’s] determination is fi-
nal and cannot be overturned. The API was manufactured
in India and India is deemed Non-[TAA] compliant.” J.A.
894. (fifth alteration added).
On March 23, 2018, Acetris filed suit in the Claims
Court challenging the VA’s interpretation of the TAA and
the FAR to exclude Acetris’ products. Acetris’ core conten-
tion was that its products, though manufactured using for-
eign-made API, are not “products of” India (under the TAA)
and are “U.S.-made end products” (under the FAR) because
they are manufactured into tablets in the United States.
The complaint recounted the VA’s position—reflected in its
March 30, 2017, April 17, 2017, June 6, 2017, February 22,
2018, and March 8, 2018 letters—that ten of Acetris’ prod-
ucts were not TAA and FAR-compliant. The complaint fur-
ther alleged that the VA “appl[ied] the VA’s improper
interpretation of the clause contrary to the FAR and in-
dicat[ed] the VA’s intent impermissibly to treat Acetris’
products as non-compliant” with the TAA and the FAR.
J.A. 110–11. Thus, Acetris contended that the VA acted
unlawfully in excluding Acetris’ products from considera-
tion for VA contracts, and Acetris requested broad declara-
tory and injunctive relief. The complaint focused
particularly on the VA’s actions in connection with Acetris’
Entecavir solicitation.
After filing the Claims Court suit, on March 28, 2018,
Acetris submitted an offer in response to the Entecavir so-
licitation. Two other entities also submitted offers: Golden
State Medical Supply, Inc. (“Golden State”) and AvKare,
Inc. Of the three bidders, Golden State offered the lowest
per-bottle price and Acetris offered the highest. The VA
awarded the contract to Golden State, consistent with the
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ACETRIS HEALTH, LLC v. UNITED STATES 9
VA’s policy to award contracts to the lowest-price techni-
cally acceptable bid.
The government moved to dismiss the Claims Court
suit on several grounds, two of which are relevant here.
First, the government contended that Acetris lacked an in-
jury sufficient to confer standing because Acetris, as the
highest-price bidder, would not have won the Entecavir
contract even if Acetris’ position as to the interpretation of
the FAR were meritorious. Second, the government con-
tended that Acetris’ earlier-filed CIT suits divested the
Claims Court of jurisdiction due to 28 U.S.C. § 1500, which
provides that the Claims Court of “shall not have jurisdic-
tion of any claim for or in respect to which the plaintiff . . .
has pending in any other court.” The Claims Court denied
the government’s motions.
The Claims Court then ruled on the parties’ cross-mo-
tions for judgment on the administrative record, rejecting
the government’s interpretation of the TAA and FAR on
the merits and agreeing with Acetris’ interpretation. The
Claims Court found that Acetris’ products were “manufac-
ture[d] . . . in a facility located in Dayton, New Jersey.”
Acetris, 138 Fed. Cl. at 586. The Claims Court then held
that the government’s interpretation of the TAA and the
FAR was incorrect and erroneously excluded Acetris’ prod-
ucts. Id. at 600–01. The Claims Court granted Acetris both
declaratory and injunctive relief. Id. at 606–07.
The government appeals. We have jurisdiction to re-
view the Claims Court’s judgment under 28 U.S.C.
§ 1295(a)(3).
DISCUSSION
We review the Claims Court decisions regarding justi-
ciability and its interpretation of the TAA and the FAR de
novo. See Trusted Integration, Inc. v. United States, 659
F.3d 1159, 1163 (Fed. Cir. 2011); Bannum, Inc. v. United
States, 404 F.3d 1346, 1351 (Fed. Cir. 2005).
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10 ACETRIS HEALTH, LLC v. UNITED STATES
I
We first address the government’s contention that the
case is moot because, after the filing of the complaint, Ace-
tris bid on the Entecavir solicitation. Acetris was not the
lowest bidder for the Entecavir solicitation, so it could not
have secured the award even if its interpretation of the
TAA and FAR were correct. The Claims Court denied the
government’s motion to dismiss the case as moot, reason-
ing that standing was to be assessed solely on the allega-
tions in the complaint, so later events were not properly
considered in determining standing. Acetris, 138 Fed. Cl.
at 595–96. That is not correct. The Supreme Court has
“repeatedly held that an ‘actual controversy’ must exist not
only ‘at the time the complaint is filed,’ but through ‘all
stages’ of the litigation.” Already, LLC v. Nike, Inc., 568
U.S. 85, 90–91 (2013). Because a lack of “controversy” is a
jurisdictional defect, Lujan v. Defs. of Wildlife, 504 U.S.
555, 559 (1992), the Claims Court should have considered
the post-filing evidence. See Int’l Elec. Tech. Corp. v.
Hughes Aircraft Co., 476 F.3d 1329, 1330 (Fed. Cir. 2007)
(“[A] court in the first instance must determine whether or
not it has subject matter jurisdiction even sua sponte.”).
This evidence demonstrates that the case is moot inso-
far as Acetris challenges the Entecavir procurement. The
VA’s Entecavir solicitation explicitly stated that the low-
est-price technically acceptable offer would be awarded the
contract. Yet Acetris submitted the highest-price offer of
the three offers. Acetris therefore would not have been
awarded the Entecavir contract even if it were correct on
the merits of its challenge to the VA’s interpretation of the
TAA and the FAR. Because Acetris cannot show prejudice
resulting from the VA’s purportedly flawed interpretation
of the TAA and the FAR as applied to the Entecavir solici-
tation, Acetris has no injury-in-fact with respect to that
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ACETRIS HEALTH, LLC v. UNITED STATES 11
solicitation. 3 See Myers Investigative & Sec. Servs., Inc. v.
United States, 275 F.3d 1366, 1370 (Fed. Cir. 2002)
(“[P]rejudice (or injury) is a necessary element of stand-
ing.”). Thus, Acetris does not now have standing to chal-
lenge the Entecavir solicitation.
A
Nonetheless, we conclude that this case is not moot be-
cause Acetris’ challenge is not limited to the Entecavir pro-
curement. We first address constitutional standing. The
government contests justiciability under Article III, argu-
ing that Acetris’ challenge as applied to future procure-
ments is “entirely hypothetical, . . . rather than an injury
that actually occurred.” Appellant’s Br. 34–35 (citing
Lujan, 504 U.S. at 560). But, as the Supreme Court has
explained, an Article III injury-in-fact may be, as it is here,
“the inability to compete on an equal footing in the bidding
process,” rather than “the loss of a contract.” Ne. Fla.
Chapter of Associated Gen. Contractors of Am. v. City of
Jacksonville, Fla., 508 U.S. 656, 666 (1993). Indeed, the
Court has found Article III standing where, as here, a pro-
spective bidder alleges that it would be unlawfully disad-
vantaged in competing for a government contract that the
bidder is “very likely” to bid on in the “relatively near fu-
ture.” Adarand Constructors, Inc. v. Pena, 515 U.S. 200,
211–12 (1995). These future procurements are virtually
certain to occur, and, absent the alleged error by the VA,
Acetris is “very likely” to bid on those procurements.
3 The parties disputed—both in the Claims Court
and in this appeal—whether the “substantial chance” test
or the “non-trivial competitive injury” test is appropriate
here. With respect to Acetris’ challenge to the Entecavir
solicitation as well as the other solicitation discussed be-
low, the result is the same regardless of the test used.
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12 ACETRIS HEALTH, LLC v. UNITED STATES
B
Acetris also has statutory standing. The statute con-
ferring bid protest jurisdiction provides in relevant part
that:
[T]he Unite[d] States Court of Federal Claims . . .
shall have jurisdiction to render judgment on an
action by an interested party objecting to a solicita-
tion by a Federal agency for bids or proposals for a
proposed contract or to a proposed award or the
award of a contract or any alleged violation of stat-
ute or regulation in connection with a procurement
or a proposed procurement. [T]he United States
Court of Federal Claims . . . shall have jurisdiction
to entertain such an action without regard to
whether suit is instituted before or after the con-
tract is awarded.
28 U.S.C. § 1491(b)(1) (emphasis added).
As relevant here, two phrases define the boundaries of
section 1491(b)(1) jurisdiction: (1) that the challenge be “in
connection with a procurement or a proposed procure-
ment”; and (2) that the challenger be an “interested party.”
Acetris broadly challenges the VA’s purportedly flawed
interpretation of “U.S.-made end products” in connection
with both existing and proposed procurements. Acetris has
standing because the government has taken a definitive
position as to the interpretation of the TAA and the FAR
that would exclude Acetris from future procurements for
other products on which it is a likely bidder. The CBP has
consistently held drug products manufactured in the
United States with API from a foreign country to be prod-
ucts of that foreign country. The government agreed at oral
argument that, “as long as the CBP decision was in place,”
there was no “reason to believe that the VA would take a
different position about the country of origin . . . in any fu-
ture contract.” Oral Argument at 18:30. Thus, there is
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ACETRIS HEALTH, LLC v. UNITED STATES 13
every indication that the VA will evaluate future bids using
the interpretation of the TAA now challenged by Acetris.
The CBP has held already at least ten of Acetris’ products
to be “products of” India, see 83 Fed. Reg. 5118, 5118–39
(Feb. 5, 2018), and, as noted in letters referenced in and
attached to the complaint, the VA has indicated on the ba-
sis of these determinations that Acetris’ products are not
TAA- and FAR-compliant. It is equally clear that the gov-
ernment will likely prohibit these products in the near fu-
ture. And, in view of Acetris’ history of performance, there
is every indication that Acetris would seek to supply and
could supply these products if it were awarded contracts for
them. See CliniComp Int’l, Inc. v. United States, 904 F.3d
1353, 1357 (Fed. Cir. 2018). Thus, Acetris has established
both a substantial chance of securing those contracts and a
“non-trivial competitive injury” as to its other products suf-
ficient to make it an “interested party.” See Weeks Marine,
Inc. v. United States, 575 F.3d 1352, 1363 (Fed. Cir. 2009);
Distributed Sols., Inc. v. United States, 539 F.3d 1340,
1344–45 (Fed. Cir. 2008) (holding that protester “deprived
of the opportunity to compete” was an “interested party”).
Acetris’ challenge also fits easily within the procure-
ment language of the statute. We have held that the word
“procurement” in section 1491(b)(1) “includes all stages of
the process of acquiring property.” See Res. Conservation
Grp., LLC v. United States, 597 F.3d 1238, 1244 (Fed. Cir.
2010) (emphasis omitted). The reference to “proposed pro-
curements” likewise broadly encompasses all contemplated
future procurements by the agency. This is not a situation
where, as in Geiler/Schrudde & Zimmerman v. United
States, 743 F. App’x 974 (Fed. Cir. 2018), the bid protester
could not identify any future procurements on which the
protester intended to bid. The future procurements are
likely to occur. And “[t]he operative phrase ‘in connection
with’ is very sweeping in scope.” RAMCOR Servs. Grp.,
Inc. v. United States, 185 F.3d 1286, 1289 (Fed. Cir. 1999).
“As long as a statute has a connection to a procurement
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14 ACETRIS HEALTH, LLC v. UNITED STATES
proposal, an alleged violation suffices to supply jurisdic-
tion.” Id. (emphasis added).
Here, since the VA’s actions under the TAA and the
FAR “so clearly affect the award and performance” of other
VA procurements on which Acetris intends to bid in the rel-
atively near future, the TAA and FAR have “a connection”
with “a procurement or proposed procurement.” See id.
Acetris’ challenge to the VA’s ruling is not moot be-
cause Acetris continues to have both constitutional and
statutory standing.
C
The government contends that Acetris’ previously filed
pending suits in the CIT, in which Acetris challenged
CBP’s country-of-origin determinations for Acetris’ prod-
ucts, divest the Claims Court of jurisdiction under 28
U.S.C. § 1500. Section 1500 provides that the Claims
Court “shall not have jurisdiction of any claim for or in re-
spect to which the plaintiff . . . has pending in any other
court.” In United States v. Tohono O’Odham Nation, 563
U.S. 307, 317 (2011), the Supreme Court interpreted sec-
tion 1500 to preclude Claims Court jurisdiction where an
earlier-filed suit is “based on substantially the same oper-
ative facts” as the Claims Court suit, “regardless of the re-
lief sought in each suit.”
We have explained that “[u]nder Tohono, the question
is whether the second Claims Court . . . suit would have
been barred by res judicata if it had been brought in district
court” under “res judicata principles as of 1868, when the
predecessor to § 1500 was first enacted.” Res. Invs., Inc. v.
United States, 785 F.3d 660, 666 (Fed. Cir. 2015) (footnote
omitted). At that time, the two tests for res judicata were
the “act or contract test” and the “evidence test.” Trusted
Integration, 659 F.3d at 1169.
Under the “act or contract test,” “[t]he true distinction
between demands or rights of action which are single and
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ACETRIS HEALTH, LLC v. UNITED STATES 15
entire, and those which are several and distinct, is, that the
former immediately arise out of one and the same act or
contract, and the latter out of different acts or contracts.”
Tohono, 563 U.S. at 316 (quoting J.C. Wells, Res Adjudi-
cata and Stare Decisis § 241, p. 208 (1878)). Under the “ev-
idence test,” two suits involve the same claim if “the same
evidence support[s] and establish[es] both the present and
the former cause of action.” Id. (quoting 2 H. Black, Law of
Judgments § 726, p. 866 (1891)). If the suits are the “same”
under either of these tests, the Claims Court suit will be
barred by section 1500. Res. Invs., 785 F.3d at 666.
Acetris’ second CIT claim is that, contrary to the CBP’s
ruling, the Acetris product is “manufactured in the [United
States]” under the FAR because the processing steps in the
United States are sufficiently “complex, time consuming,
and expensive.” CIT Complaint ¶¶ 86–94. The CBP had
no colorable authority to opine on the FAR (i.e., the second
CIT claim), which is a matter solely of procurement law.
The CBP’s statutory authority to provide country-of-origin
determinations comes from 19 U.S.C. § 2515(b)(1), which
only authorizes “determinations . . . under section
2518(4)(B) of this title.” Section 2518(4)(B) provides the
TAA’s statutory country-of-origin test, which is different
from the FAR’s test. The CIT thus lacks colorable jurisdic-
tion to review the merits of a CBP decision on Acetris’ FAR
compliance (which the CBP did not have authority to make
in the first instance). Accordingly, any decision by the CIT
on this claim would not have res judicata effect, and any
factual allegations in the CIT complaint pertaining only to
this claim do not have preclusive effect under section
1500. 4
4
Tohono held that, under section 1500, a claim filed
at a first court can divest the Claims Court of a second,
later-filed claim even where the first court would have
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16 ACETRIS HEALTH, LLC v. UNITED STATES
We next turn to the first CIT claim, which involves the
TAA, at issue in both the CIT and the Claims Court cases.
Neither the “act or contract” test nor the “evidence” test
supports a section-1500 bar. As to the “act or contract” test,
the CIT cases challenge the CBP’s act of issuing a TAA de-
termination. In contrast, the Claims Court case challenges
the actions of a different government agency—the VA—in
adopting an interpretation of the TAA (and the FAR) that
excludes products manufactured in the United States with
foreign-made API (including, but not limited to, Acetris’
products) from government procurements. Thus, the CIT
and Claims Court suits do not “immediately arise out of one
and the same act.” See Tohono, 563 U.S. at 316 (citation
omitted).
lacked subject-matter jurisdiction over the second claim.
Tohono, 563 U.S. at 315–17. This represents a departure
from the usual rule that res judicata cannot preclude a
later-filed claim over which the first court lacked jurisdic-
tion. See Res. Invs., 785 F.3d at 666. But in Tohono the
earlier-filed claims were properly filed in the district court;
Tohono did not consider situations where, as here, the first
court lacks jurisdiction over the earlier-filed claim. And we
do not read Tohono to override the principle that a court
cannot rule on the merits of—and thus res judicata effect
cannot arise from—a claim over which the court has no col-
orable jurisdiction. Restatement (Second) of Judgments
§ 12 (1982) (no preclusion where “[t]he subject matter of
the action was so plainly beyond the court’s jurisdiction
that its entertaining the action was a manifest abuse of au-
thority”); see also United States v. U. S. Fid. & Guar. Co.,
309 U.S. 506, 512 (1940) (holding that res judicata did not
apply where district court had no statutory authority to ad-
judicate a claim against the United States); Christopher
Vill., L.P. v. United States, 360 F.3d 1319, 1326–33 (Fed.
Cir. 2004).
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ACETRIS HEALTH, LLC v. UNITED STATES 17
As to the “evidence” test, Acetris’ first CIT claim has
some factual overlap with the Claims Court claim. But
many of the VA actions challenged in Acetris’ Claims Court
complaint occurred after the CIT complaints were filed and
are not challenged in the CIT claims. And, to the extent
that there is overlap between those claims, it largely in-
volves the “res gestae,” not the “operative facts,” of the
claims. See Trusted Integration, 659 F.3d at 1170; see, e.g.,
Complaint, Acetris Health LLC v. United States, No. 18-47
(Ct. Int’l Trade Mar. 7, 2018), ECF No. 4 [hereinafter “CIT
Complaint”], ¶¶ 79–85.
The CIT and Claims Court claims are not the “same”
under the evidence test. With respect to the first CIT
claim, Acetris contends that its products are TAA-
compliant because they are “products of the United States”
having been “substantially transformed” in the United
States under 19 U.S.C. 2518(4)(B). In contrast, at the
Claims Court, Acetris contends that its products are TAA-
compliant because they are not “products of India” since
they are neither “wholly the . . . manufacture” of India nor
“substantially transformed” in India. These claims are not
based on the same evidence. The “products of the United
States” question in the CIT turns on whether a substantial
transformation occurred in the United States. The “prod-
uct of India” question in the Claims Court turns on whether
the product was “wholly the . . . manufacture” of or “sub-
stantially transformed” in India. Thus, an adverse decision
on the factual assertion that forms the basis for Acetris’
CIT claim—that the processing steps in New Jersey cause
a “substantial transformation” of the product from its con-
stituent API sufficient to result in a “product of the United
States” under the TAA—cannot preclude Acetris’ Claims
Court claim asserting that the product is not a “product of
India” because the product is neither “wholly the . . . man-
ufacture” of India nor “substantially transformed” in India.
Because the evidence at issue in the CIT cases does not
“support and establish” the Claims Court claims, the
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18 ACETRIS HEALTH, LLC v. UNITED STATES
evidence test does not bar jurisdiction here. See Tohono,
563 U.S. at 316 (emphasis added); see also Trusted Integra-
tion, 659 F.3d at 1170 (noting that “under the evidence test
. . . the overlapping evidence need[s] to be both relevant to
and legally operative to prove the prior claim before res ju-
dicata [acts] as a bar to the subsequent claim” (emphasis
in original)).
Section 1500 does not preclude jurisdiction here.
II
A
Turning to the merits, the government contends that
the CBP’s country-of-origin determinations are “binding”
on the VA and so left no discretion to the VA to conduct an
“independent [country-of-origin] analysis.” Appellant’s Br.
48. We reject that argument. As the Claims Court noted,
“the procuring agency”—here, the VA—is “responsible for
determining whether an offered product qualifies as a U.S.-
made end product.” Acetris, 138 Fed. Cl. at 602–03. In-
deed, as the government admitted at oral argument, there
is “not a requirement” for the VA to defer to the CBP’s de-
termination.
B
We conclude that the VA’s interpretation of the TAA
and the FAR was erroneous, as the Claims Court held. The
TAA provides in relevant part that “the President . . . shall,
with respect to procurement covered by the [WTO Agree-
ment], prohibit the procurement . . . of products . . . which
are products of a foreign country or instrumentality which
is not designated pursuant to section 2511(b) of this title.”
19 U.S.C. § 2512(a)(1). The question here is whether Ace-
tris’ products, which are made into tablets in the United
States using API made in India, are “products of” India for
which procurement is prohibited by the TAA. The TAA’s
rule-of-origin test provides that:
Case: 18-2399 Document: 53 Page: 19 Filed: 02/10/2020
ACETRIS HEALTH, LLC v. UNITED STATES 19
An article is a product of a country or instrumen-
tality only if (i) it is wholly the growth, product, or
manufacture of that country or instrumentality, or
(ii) in the case of an article which consists in whole
or in part of materials from another country or in-
strumentality, it has been substantially trans-
formed into a new and different article of commerce
with a name, character, or use distinct from that of
the article or articles from which it was so trans-
formed.
19 U.S.C. § 2518(4)(B) (emphasis added).
The government argues that Acetris’ tablets are prod-
ucts of India because the tablets’ API was made in India.
But the government cannot identify any Supreme Court or
Circuit authority holding that a pharmaceutical product’s
country-of-origin is determined by the country in which its
API was manufactured. To the contrary, it is clear from
the TAA that the “product” is the final product that is pro-
cured—here, the pill itself—rather than the ingredients of
the pill. Acetris’ tablets do not meet prong (i) of the TAA’s
country-of-origin test for India because the tablets are not
“wholly the . . . manufacture” of India. Acetris’ tablets sim-
ilarly do not meet prong (ii) because the tablets’ compo-
nents are not “substantially transformed” into tablets in
India. Because an article is a product of a country “only if”
prongs (i) or (ii) are met, Acetris’ tablets are therefore not
a “product of” India. Indeed, the government concedes that
under the construction of “product” that we have adopted
(i.e., that “the pill is the product”), “the pill is not the prod-
uct of India.” Oral Argument at 11:50–12:50.
Accordingly, since the TAA only excludes products from
government procurement if they are “products of” a foreign
country like India, the TAA does not bar the VA from pro-
curing Acetris’ products.
The FAR also does not bar Acetris’ products. The
FAR’s Trade Agreements (“TA”) Clause provides in
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20 ACETRIS HEALTH, LLC v. UNITED STATES
relevant part that “[t]he Contractor shall deliver under this
contract only U.S.-made . . . end products.” FAR § 52.225­5.
The FAR does not adopt the TAA’s country-of-origin test
for determining what are “products of a foreign country or
instrumentality.” 19 U.S.C. § 2518(4)(B). Instead, the
FAR defines “U.S.-made end product” as “an article that is
mined, produced, or manufactured in the United States or
that is substantially transformed in the United States.”
FAR § 25.003.
The regulatory history of the term “U.S.-made end
product” makes clear that the source of the components
(here, the API) is irrelevant in determining where a prod-
uct is “manufactured.” When the term was introduced to
the FAR, the government explained it as follows: “[t]he pro-
posed rule defines U.S. made end products as products that
are manufactured or substantially transformed in the
United States, regardless of the source of the components.”
Federal Acquisition Regulation; Foreign Acquisition (Part
25 Rewrite), 63 Fed. Reg. 51642 (Sept. 28, 1998) (emphasis
added). A product need not be wholly manufactured or sub-
stantially transformed in the United States to be a “U.S.-
made end product.” Instead, such products may be—as
Acetris’ products are—“manufactured” in the United
States from foreign-made components. The solicitation
here similarly provides that “the place of manufacture is
the location ‘where ingredients are measured, weighed,
mixed and compounded.’” J.A. 100. The government does
not dispute that Acetris’ products are measured, weighed,
mixed and compounded in—and so, under the VA’s own
definition, “manufactured” in—a facility in Dayton, New
Jersey. See Acetris, 138 Fed. Cl. at 586; Oral Argument at
4:10 (government stating that the “pill form [of an Acetris
product] is made in New Jersey”). Therefore, on the plain
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ACETRIS HEALTH, LLC v. UNITED STATES 21
meaning of the FAR, Acetris’ products are “U .S.-made end
products.” 5
The government cites the Supreme Court’s decision in
Anheuser–Busch Brewing Ass’n v. United States, 207 U.S.
556 (1908), for the proposition that the terms “‘manufac-
ture’ and ‘substantial transformation’ share a common
meaning” (i.e., that there cannot be a “manufacture” with-
out a “substantial transformation”). Appellant’s Reply Br.
14–16. To the government, Acetris’ products are not “man-
ufactured” in the United States because they are not sub-
stantially transformed in the United States. Even
assuming (without deciding) that Acetris’ products are not
substantially transformed in the United States, 6 the gov-
ernment’s argument fails. Under Anheuser–Busch, the
“first sense” of the term “manufacture” is when “a new ar-
ticle is produced of which the imported material constitutes
an ingredient or part.” Anheuser–Busch, 207 U.S. at 562.
That definition is clearly satisfied here; the India-made
5 The Claims Court concluded and Acetris argues ex-
tensively on appeal that the term “U.S.-made end prod-
ucts” necessarily includes “domestic end products” (i.e.,
BAA-compliant products). This is not the relevant inquiry.
Products that, like Acetris’ products, are “manufactured in
the United States” and so are “U.S.-made end products”
whether or not they meet the other requirements of “do-
mestic end products” (i.e., that they are COTS items or
their components are at least 50% (by cost) American-
made). See FAR § 25.003; J.A. 881 (VA solicitation stating
that “the Government will evaluate offers of U.S.-made or
designated country end products without regard to the re-
strictions of the Buy American statute”).
6 Acetris’ products may very well be substantially
transformed in the United States, but we need not decide
this question here.
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22 ACETRIS HEALTH, LLC v. UNITED STATES
API “constitutes an ingredient or part” of the tablets pro-
duced in New Jersey.
To be sure, Anheuser–Busch construed the word “man-
ufacture” to also require that “a new and different article
must emerge, ‘having a distinctive name, character, or
use,’” 207 U.S. at 560 (quoting Hartranft v. Wiegmann, 121
U.S. 609, 615 (1887)), a construction that has since been
referred to as the “substantial transformation” test. But,
under the FAR, a “U.S.-made end product” may either be
(i) “manufactured in the United States”; or (ii) “substan-
tially transformed in the United States.” FAR § 25.003.
The language of the FAR reflects an intent not to require
“substantial transformation” for analysis under the FAR;
“manufacture” does not require substantial transfor-
mation.
If the government is dissatisfied with how the FAR de-
fines “U.S.-made end product,” it must change the defini-
tion, not argue for an untenable construction of the existing
definition.
III
Having concluded that Acetris is correct on the merits,
we turn to the issue of remedy. The Claims Court granted
Acetris the following relief:
[T]he court DECLARES that:
The term “U.S.-made end product,” as used
in the Trade Agreements clause, includes
“domestic end products,” as that term is de-
fined in the FAR.
The VA’s failure to construe the term “U.S.-
made end product,” as used in the Trade
Agreements clause, to include “domestic
end products,” as that term is defined in
the FAR, was arbitrary, capricious, and
contrary to law.
Case: 18-2399 Document: 53 Page: 23 Filed: 02/10/2020
ACETRIS HEALTH, LLC v. UNITED STATES 23
It was arbitrary and capricious for the VA
to require manufacturers to certify that the
offered products were “[Trade Agreements
Act] compliant.”
The VA’s failure to independently assess
whether plaintiff’s Entecavir Tablets qual-
ified as U.S.-made end products under the
Trade Agreements clause was arbitrary,
capricious, and contrary to law.
In addition, the court ENJOINS the VA, in future
procurements, from
construing the term “U.S.-made end prod-
uct” in the Trade Agreements clause as ex-
cluding products manufactured in the
United States (in other words, domestic
end products), and
relying on CBP rather than independently
ascertaining whether an offered product is
manufactured in the United States (in
other words, a domestic end product) pur-
suant to the definition of the term “U.S.-
made end product.”
J.A. 89 (second brackets in original).
We find that the Claims Court judgment is both impre-
cise and confusing. On remand, the Claims Court should
declare that: (1) under the TAA, a pharmaceutical product
using API made in India does not, because of that fact,
thereby become the “product of” India; and (2) under the
FAR, the term “U.S.-made end product” may include prod-
ucts manufactured in the United States using API made in
another country. The Claims Court should also enjoin the
VA from excluding Acetris’ products manufactured in Au-
rolife’s Dayton, New Jersey facility from future procure-
ments.
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24 ACETRIS HEALTH, LLC v. UNITED STATES
CONCLUSION
We conclude that this case is justiciable, and that the
VA erred in interpreting the TAA and the FAR to exclude
pharmaceutical products that, like Acetris’ products, are
manufactured in the United States using API made in a
foreign country. Such products are not, under the TAA, the
“product of” the country in which their API was made, and
are “U.S.-made end products” under the FAR. We remand
the case for the Claims Court to enter judgment consistent
with this opinion.
AFFIRMED-IN-PART, VACATED-IN-PART, AND
REMANDED
COSTS
No costs.